New Drug Application

Ivax got federal permission to sell a generic drug to treat arthritis, its first new product approval in some time. The Miami-based pharmaceutical firm said on Wednesday it plans to make naproxen in tablets of 250, 375 and 500 milligrams through its Zenith Laboratories subsidiary acquired in December. Naproxen was developed by Syntex Corp., which sells it under the brand name Naprosyn. Generics are copies of proprietary drugs no longer protected by patents. They are typically less expensive than brand-name drugs.

Kos Pharmaceuticals Inc., which moved its corporate headquarters in 2004 to Cranbury, N.J., from Miami, actually has a growing presence in South Florida. On Tuesday, the company opened a 96,000-square-foot building in a Weston industrial park. "We continue to invest in South Florida, and we have several very defined groups and functions here," said Adrian Adams, chief executive officer of Kos. He said 240 of the company's 300 South Florida employees are based in Weston, working in financial, clinical compliance, information technology and other areas.

Kos Pharmaceuticals Inc., which moved its corporate headquarters in 2004 to Cranbury, N.J., from Miami, actually has a growing presence in South Florida. On Tuesday, the company opened a 96,000-square-foot building in a Weston industrial park. "We continue to invest in South Florida, and we have several very defined groups and functions here," said Adrian Adams, chief executive officer of Kos. He said 240 of the company's 300 South Florida employees are based in Weston, working in financial, clinical compliance, information technology and other areas.

Florida Atlantic University officials in Boca Raton have licensed rights to a therapy intended to treat a pre-cancerous skin condition commonly found in Florida. Two medical industry entrepreneurs now hope to further develop and market the discovery. The potential product, a topical gel consisting of an existing cancer drug whose patent has expired and another chemical compound that adds a modified form of oxygen, could provide a simple way to treat actinic keratosis -- lesions that appear on the face and other parts of the body most often exposed to the sun. The FAU-developed therapy would require clinical trials, and is at least several years away from the market.

Andrx, of Fort Lauderdale, received tentative Food and Drug Administration approval Monday of its abbreviated new drug application for a generic version of blockbuster medication Prilosec -- and Wall Street applauded. Investors propelled the stock price up $18.94 to an all-time closing high of $125 on volume of 849,100 shares, almost 1 times the average. At one point, the price reached $128.81. Andrx won't be able to market its generic form of the drug, which is used to treat duodenal and gastric ulcers and gastro-esophageal reflux disease, until 2001.

The highly addictive painkiller OxyContin, first introduced in 1996, was so heavily marketed by Purdue Pharma that it accounted for 90 percent of the company's business by 2001 and 2002 and sales exceeded $1 billion in each of those years, according to a report issued Thursday by the U.S. General Accounting Office, the investigative arm of Congress. To accomplish such growth, the company strategy included inviting doctors to pain management seminars in resort areas such as Boca Raton and Scottsdale, Ariz.

Florida Atlantic University officials in Boca Raton have licensed rights to a therapy intended to treat a pre-cancerous skin condition commonly found in Florida. Two medical industry entrepreneurs now hope to further develop and market the discovery. The potential product, a topical gel consisting of an existing cancer drug whose patent has expired and another chemical compound that adds a modified form of oxygen, could provide a simple way to treat actinic keratosis -- lesions that appear on the face and other parts of the body most often exposed to the sun. The FAU-developed therapy would require clinical trials, and is at least several years away from the market.

Shares of Miami-based Noven Pharmaceuticals Inc. jumped more than 18 percent on Monday after the company's announcement that the Food and Drug Administration denied citizen petitions intended to prevent or delay the approval of its generic versions of Johnson & Johnson Inc.'s Duragesic skin patch for chronic pain. Noven stock closed at $18.22, up $2.82, as 2.5 million shares changed hands -- more than eight times the average daily volume. An abbreviated new drug application for Noven's patch is pending at the FDA, and the product has been licensed in the United States and Canada to Endo Pharmaceuticals Holdings Inc. Endo shares closed at $21.06, up 36 cents.

Dainippon Sumitomo Pharma Co. is acquiring U.S. drug-maker Sepracor Inc., which makes insomnia drug Lunesta, for about $2.6 billion in an effort to expand in the U.S. market, the companies said Thursday. The Japanese drug-maker said the deal will give it access to Sepracor's established sales network of about 1,325 people in the U.S., which will help it establish a sales platform for lurasidone, a potential treatment for schizophrenia that is now in late-stage trials. Dainippon said it plans to submit a new drug application for lurasidone to the U.S. Food and Drug Administration in early 2010.

Columbia Laboratories may finally climb into the black if Chief Operating Officer Nick Buoniconti is right about his company's hormone replacement therapy. Since 1987, Columbia Labs has posted an unbroken string of quarterly losses that total more than $45 million trying to market a technology that delivers medication through the mucous membranes. Buoniconti, a former all-pro linebacker with the Miami Dolphins, joined the firm two years ago as it dropped marketing efforts to focus on developing products to be sold by others.

The highly addictive painkiller OxyContin, first introduced in 1996, was so heavily marketed by Purdue Pharma that it accounted for 90 percent of the company's business by 2001 and 2002 and sales exceeded $1 billion in each of those years, according to a report issued Thursday by the U.S. General Accounting Office, the investigative arm of Congress. To accomplish such growth, the company strategy included inviting doctors to pain management seminars in resort areas such as Boca Raton and Scottsdale, Ariz.

Andrx, of Fort Lauderdale, received tentative Food and Drug Administration approval Monday of its abbreviated new drug application for a generic version of blockbuster medication Prilosec -- and Wall Street applauded. Investors propelled the stock price up $18.94 to an all-time closing high of $125 on volume of 849,100 shares, almost 1 times the average. At one point, the price reached $128.81. Andrx won't be able to market its generic form of the drug, which is used to treat duodenal and gastric ulcers and gastro-esophageal reflux disease, until 2001.

Ivax got federal permission to sell a generic drug to treat arthritis, its first new product approval in some time. The Miami-based pharmaceutical firm said on Wednesday it plans to make naproxen in tablets of 250, 375 and 500 milligrams through its Zenith Laboratories subsidiary acquired in December. Naproxen was developed by Syntex Corp., which sells it under the brand name Naprosyn. Generics are copies of proprietary drugs no longer protected by patents. They are typically less expensive than brand-name drugs.

* Miami-based Union Planters, parent company of Union Planters Bank of Florida, has been cited as one of the most small-business friendly bank holding companies in the nation by the U.S. Small Business Administration's Office of Advocacy. Union Planters was the only company cited with a Florida presence. An SBA study reported a significant increase in the number of small-business loans in 1996 and 1997. A small-business loan is defined as one of less than $250,000. HEALTH CARE * Hoping to crack a half-billion-dollar annual market for a cancer-treating drug now dominated by a single company, Immunex and IVX BioScience of Miami will collaborate to market generic paclitaxel products.

In a move designed to speed U.S. development of the abortion pill RU-486, the French manufacturer donated its patent rights to a non-profit group on Monday. The step was taken with a view toward clinical trials and licensing of the drug in the United States by 1996. The unusual arrangement, encouraged by the Clinton administration, overcame a major obstacle to widespread use of RU-486 in the United States. But the drug still must be declared safe and effective by the Food and Drug Administration before it can be made available.